MAUDE Adverse Event Report: GYRUS ACMI, INC EZDILATE BALLOON DILATOR (FW) 18-19-20

Model Number BD-400P-2080

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device was discarded by the customer.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined.The service center will continue to investigate this report to obtain more detailed information regarding the reported event.If additional information becomes available at a later date, this report will be updated and a supplemented accordingly.

Event Description

The service center was informed that during an unspecified procedure that the balloon was fully deflated and could not retracted back into the scope.The surgeon was able to remove the scope from the patient without any injury.The intended procedure was completed with the same device.Additionally, the device was inspected prior to use and no abnormalities were found.This is 2 of 2 reports.

Manufacturer Narrative

The referenced device was not returned for evaluation, therefore, the cause reported "not being able to remove the deflated balloon from the scope" cannot be determined since the device was discarded by the user facility.Thirteen similar complaints for retrieval issues have been received in the last 12 months for this part number.However, unable to confirm seven of these complaints as the device was not returned.Six devices were returned but the nonconformance was not confirmed.The dhr for the concerned device was reviewed; no abnormalities in documentation or process were noted.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 18-19-20
• Type of Device: EZDILATE BALLOON DILATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8716108
• MDR Text Key: 148561188
• Report Number: 2951238-2019-00963
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-KNQ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD-400P-2080
• Device Lot Number: 513128A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1